(48 days)
Smith & Nephew Light Sources, light guides and accessories are indicated for use with the Subcutaneous Illuminator for the purpose of providing transillumination during endoscopic resection of superficial varicosities of the lower extremities.
Smith & Nephew Light Sources, Light Guides and accessories are designed to transmit light to the surgical site via fiberoptic bundles in the light guide. The light guides mate to the Subcutaneous Illuminator and Light Source with instrument specific adapters.
This 510(k) summary does not contain the information required to answer your request. It is a submission for a medical device (Smith & Nephew Light Sources and Accessories) that relies on substantial equivalence to existing predicate devices.
Here's why the requested information is not available in these documents:
- Acceptance Criteria and Device Performance: The document states, "The basic design and function of the Smith & Nephew Light Sources and Accessories are unchanged compared to information provided in previous submissions." This indicates that no new performance studies were conducted, and therefore, no new acceptance criteria or reported device performance metrics are provided in this submission. The FDA's letter also confirms substantial equivalence rather than a new approval based on performance data.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no new performance study was performed for this 510(k) submission, there are no details about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information. These details are typically found in documents describing the validation of a new or significantly modified device, especially AI/ML-driven devices.
In essence, this document is a regulatory filing asserting that the new version of the light sources and accessories is essentially the same as previous, cleared versions, and thus does not require new performance testing.
{0}------------------------------------------------
JAN 20 2000
510(k) Summary Smith & Nephew Light Sources And Accessories Date Prepared: 12/01/99
Endoscopy Division
Smith & Nephew, Inc.
160 Dascomb Road, Andover, MA 01810 U.S.A.
Telephone: 978-749-1000
Telefax: 978-749-1599
This 510(k) summary is bcing submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 160 Dascomb Road Andover, Massachusctts 01810
B. Company Contact
Janice Haselton Regulatory Affairs Specialist
C. Device Name
| Trade Name: | Smith & Nephew Light Sources and Accessories |
|---|---|
| Common Name: | Light Sources and Accessories |
| Classification Name: | Fiberoptic Illuminator, 21 CFR 876.1500 |
D. Predicate Devices
The predicate devices for this submission are the existing line of Smith & Nephew Xenon Light Sources, Light Guides and accessories.
Description of Device
Smith & Nephew Light Sources, Light Guides and accessories are designed to transmit light to the surgical site via fiberoptic bundles in the light guide. The light guides mate to the Subcutaneous Illuminator and Light Source with instrument specific adapters.
Intended Usc E.
Smith & Nephew Light Sources, light guides and accessories are indicated for use with the Suboutancous Illuminator for the garast and accossories are indivation during endoscopic resection of superficial varicosities of the lower extremities.
F. Comparison of Technological Characteristics
The basic design and function of the Smith & Nephew Light Sources and Accessories are unchanged compared to information provided in previous submissions.
James Haselton
Janied Haselton Regulatory Affairs Specialist
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
JAN 20 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janice Haselton Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810
Re: K994084
Trade Name: Smith & Nephew Xenon Light Source and Accessories Regulatory Class: II Product Code: FFS Datcd: Dccember 2, 1999 Received: December 3, 1999
Dear Ms. Haselton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
{2}------------------------------------------------
Page 2 - Ms. Janice Haselton
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 007.10 for millionally, for questions on the promotion and advertising of your device, (301) 594-4539. Auditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsive this toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Styp Rhodes
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number :
Device Name : Smith & Nephew, Light Sources and Accessories
Indications for Use :
Smith & Nephew Light Sources, light guides and accessories are indicated for use with the Subcutaneous Illuminator for the purpose of providing transillumination during endoscopic resection of superficial varicosities of the lower extremities.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hugh K. Edwards
Division of General Restorative Devices K994084 S10(k) Number.
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.